Medtronic, Inc. : Medtronic Initiates Landmark Study of Neurostimulation
Therapy for Failed Back Surgery Syndrome
First Patients Treated in Global Clinical Trial Evaluating Impact of Therapy
on Predominant Low Back Pain
MINNEAPOLIS - January 28, 2013 - Medtronic, Inc. (NYSE: MDT) today announced
the start of PROMISE, a Prospective, Randomized Study of Multicolumn
Implantable Lead Stimulation for Predominant Low Back Pain. This is the
first-ever, large-scale study comparing the effectiveness of Medtronic
neurostimulation therapy with Specify^® 5-6-5 multicolumn surgical leads plus
optimal medical management (OMM) to the administration of OMM alone in
patients with failed back surgery syndrome (FBSS) and predominant low back
"Chronic pain is a clinically challenging and often debilitating condition for
which oral medications may provide insufficient relief," said Bart Edmiston,
M.D., principal investigator for the PROMISE study at The Neuroscience Center
in Ocean Springs, Mississippi, which enrolled the study's first patient on
January 8. "The PROMISE study will add to the growing body of evidence
supporting Medtronic neurostimulation therapy, a well-established therapeutic
approach, for the patients worldwide who continue to experience low back pain
following back surgery."
It is estimated that more than 100 million U.S. adults^1 and one in five
European adults^2 live with chronic pain. Back pain is the most prevalent type
of chronic pain, affecting approximately 10 percent of the U.S. population
alone.^3 FBSS is defined as persistent or recurring pain in the back or legs
following one or more spine surgeries. The majority of FBSS patients receive
physical rehabilitation and/or oral medications to help manage their pain, but
studies and clinical experience find that many of these patients will not
sufficiently improve and will require additional interventions.^4
Medtronic neurostimulation therapy (also known as spinal cord stimulation, or
SCS) is a widely established treatment option for chronic back and/or leg pain
that has been used to treat more than 250,000 people worldwide. It uses a
medical device to deliver mild electrical impulses to the spinal cord to block
pain signals from reaching the brain.
PROMISE is a prospective, randomized, open-label, parallel-group, clinical
study enrolling up to 300 individuals suffering from predominant chronic low
back pain due to FBSS at 30 centers in the United States , Canada and Europe
(Belgium, France, Germany, Spain, The Netherlands and The United Kingdom). It
is the first large-scale, randomized, controlled clinical trial designed to
assess the value of SCS for predominant low back pain with leg pain using a
surgical lead, in contrast to previous studies of this technology, which have
focused on predominant leg pain.
"Spinal cord stimulation has become an increasingly valued treatment approach
in chronic pain, and we look forward to participating in the latest study,"
said Philippe Rigoard, M.D., the study's global principal investigator, who
started enrolling patients January 14 at Poitiers University Hospital in
Poitiers, France. "If the PROMISE results are positive, they will provide
critically needed relief for those patients suffering from chronic low back
pain associated with FBSS."
PROMISE participants will be randomized 1:1 to receive treatment with either
SCS with OMM or OMM only. After a six-month observational phase, the study
will compare the proportion of participants in the SCS group who report more
than 50 percent reduction in low back-pain intensity, as measured by the
Numeric Pain Rating Scale, with those in the OMM-only group. Health care
utilization data collected will be used to develop cost analysis models for
potential use in future studies evaluating the long-term economic impact of
"Medtronic is committed to advancing the understanding of its neurostimulation
therapy in patients with low back pain resulting from FBSS," said Julie
Foster, general manager and vice president, Pain Stimulation and Targeted Drug
Delivery in the Neuromodulation business of Medtronic, Inc. "PROMISE provides
the opportunity to assess not only the degree of pain relief provided by SCS
plus OMM compared to OMM alone in failed back surgery patients, but also to
evaluate the economic and quality of life impact of this treatment by looking
at such important measures as sleep, ability to work and changes in pain
More information about the PROMISE study, including enrollment information,
can be obtained at
Medtronic's Leadership in Neuromodulation
Medtronic developed and leads the field of neuromodulation, the targeted and
regulated delivery of electrical pulses and pharmaceuticals to specific sites
in the nervous system. The company's Neuromodulation business includes
implantable neurostimulation and targeted drug delivery systems for the
management of chronic pain, common movement disorders, spasticity and urologic
and gastrointestinal disorders.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the
global leader in medical technology - alleviating pain, restoring health and
extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities
and Exchange Commission. Actual results may differ materially from anticipated
- end -
1 Relieving Pain in America: A Blueprint for Transforming Prevention, Care,
Education, and Research; Consensus Report, Institute of Medicine (IOM), June
2011. Page 1.
2Breivik H, Collett B, Ventafridda V, Cohen R, Gallagher D. Survey of chronic
pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain
3Hardt J, Jacobsen C, Goldberg J, Nickel R, Buchwald D.: Prevalence of chronic
pain in a representative sample in the United States. Pain Medicine 2008; 9:7:
0nstitute of Medicine (IOM), s are estimated tople in the United States.
sequent implants depending on levell ulation to area803-812.
4Chan C, Peng P. Review Article: Failed Back Surgery Syndrome. Pain Medicine
2011; 12: 577-606.
+44 7825 889 607
This announcement is distributed by Thomson Reuters on behalf of Thomson
The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
information contained therein.
Source: Medtronic, Inc. via Thomson Reuters ONE
Press spacebar to pause and continue. Press esc to stop.